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Evaluation of HIV-1, HCV and HBV Blood Screening Tests With Human Blood Donor Specimens

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2007 by Novartis.
Recruitment status was:  Enrolling by invitation
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00552214
First received: October 30, 2007
Last updated: November 5, 2007
Last verified: October 2007

October 30, 2007
November 5, 2007
August 2007
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Sensitivity and Specificity [ Time Frame: 01 August 2007 to 31 December 2007 ]
Same as current
Complete list of historical versions of study NCT00552214 on ClinicalTrials.gov Archive Site
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Evaluation of HIV-1, HCV and HBV Blood Screening Tests With Human Blood Donor Specimens
Evaluation of a TMA Assay for the Screening of HIV-1 RNA, HCV RNA and HBV DNA in Human Blood Donor Plasma Specimens
The purpose of this study is to validate the performance characteristics of an assay that tests for HIV-1, HCV and HBV on an automated blood bank instrument for registration submission.
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Interventional
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Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
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Device: Blood test
Screening of HIV-1 RNA, HCV RNA and HBV DNA in Human Blood Donor Plasma Specimens
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
10500
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Inclusion Criteria:

  • An acceptable blood donation health history and an EIA negative donation sample result with licensed EIA procedures in routine use at each facility

Exclusion Criteria:

  • A positive (reactive) HIV and/or HCV and/or HBV test
Sexes Eligible for Study: All
17 Years to 65 Years   (Child, Adult)
Not Provided
Contact information is only displayed when the study is recruiting subjects
Taiwan
 
 
NCT00552214
ULT-001-TW1-Amendment 1.1
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Novartis
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Study Director: Judith Blunt Novartis
Novartis
October 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP